manveer Pharmacovigilance

8/14/2019 manveer Pharmacovigilance

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Pharmacovigilance

:- manveer kashinwar


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What is Pharmacovigilance ?

Pharmacovigilance is the science and activitiesrelating the detection , assessment,understanding, and preventaion of adverse

effects or any other possible drug releatingproblems.


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Terms

Adverse Event (AE) any untoward medicaloccurrence that may present during treatmentwith a pharmaceutical product but which does

not necessarily have a casual relationship withthis treatment

Adverse Drug Reaction (ADR) a response toa drug which is noxious and unintended, and

which occurs at doses normally used in man.


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Terms

Signal reported information on a possiblerelationship between an adverse event and adrug, unknown or incompletely documented

previously. Usually more than a single report isrequired to generate a signal, depending uponthe seriousness of the event and the quality ofthe information


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Importance of pharmacovigilance

in every country?


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Aim of pharmacovigilance

improve patient care and safety as well as

improve public health and safety in relation tothe use of medicines.

Contribute to the assessment of benefit , harmeffectiveness and rish of medicines.


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New Drug Approval Process

Each new drug (New Chemical Entity,NCE) shall prove its safety and efficacyin order to gain marketing authorization

Scientific data on efficacy/safety arecollected in clinical trials

If a drug meets all safety (and efficacy)requirements New Drug Application(NDA) is submitted to regulatory agency

Regulatory agency reviews theapplication, may require further studies.

It issues Marketing Authorization (MA)or reject application, guided byrisk/benefit evaluation

Research of drug safety continues afterdrug is introduced in clinical praxis aspost-marketing surveillance (phase IV

study)


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Sources of Information on Drug Safety

Pre-clinical studies

Clinical trials (pre- and post-marketing)

Spontaneous adverse reaction reporting

Epidemiological studies

Data collected for other purposes

Routine statistics

Databases of prescription and outcomes


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Pre-clinical Studies

Standard toxicology pre-clinical tests are:

Acute toxicity

Repeat use toxicity

Local irritation tests Pyrogenity

Reproductive toxicity

Mutagenity Carcinogenity


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Clinical Trials

Principal aim of clinical is to collect safety (and efficacy) data.The investigational drug shall prove safety profile consistentwith human testing on base of pre-clinical studies. Clinical trialsare subject of regulatory approval.

The sponsor shall keep detailed records of all adverse eventsand he shall submit these records on request of regulatoryauthority.

The sponsor shall ensure that all relevant information aboutsuspected serious unexpected adverse reactions have to be

recorded and reported to regulatory authority Other investigators participating in multicentric trials shall also

be informed on serious unexpected adverse events


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Clinical Trials

Safety profile of investigational drug is described inInvestigator`s Brochure (likewise SPC in marketed drugs

Procedures for reporting of adverse events in clinical trialsslightly differ from post-approval reporting. Standard are CIOMS

forms, electronic reporting is now preferred Detailed guidance on the collection, verification and

presentation of adverse reactions reports arising from clinicaltrials on medicinal products for human use, EuropeanCommission, April 2006

Serious events such as deaths are relatively rare and maypresent reason for termination of a clinical trial


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Rationale for Post-Marketing Surveillance

Tests in animals are insufficiency predictive of humansafety

In clinical trials patients are selected and limited innumber

Conditions of use in trials differ from those in clinicalpractice

Duration of trials is limited

Information about rare but serious adverse reactions,chronic toxicity, use in special groups such aschildren, the elderly or pregnant woman or druginteractions is often not available


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Who Should Report Safety Data

Physicians

Pharmacists

Pharmaceutical companies qualified persons (Pharmacovigilence/Regulatory manager) Investigational products (clinical trials)

Post-approval reporting Individual Case Safety

Report (ICSR), Periodic Safety Update Report(PSUR)

In many countries patients are encouraged (butnot obligated) to report side effects


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What to Report WHO recommendations

Every single problem related to the use of a drug, becauseprobably nobody else is collecting such information

All suspected adverse reactions

ADRs associated with radiology contrast media, vaccines,diagnostics, drugs used in traditional medicine, herbalremedies, cosmetics, medical devices and equipment

Lack of efficacy and suspected pharmaceutical defects

Counterfeit pharmaceuticals Development of resistance


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What to Report (at least)

Requirements for reporting differ from country to country. However, ineach developed country healthcare professionals are legallyobligated to report adverse reactions (although it is not always clearlystated which)

It is important to report serious unexpected ADRs those that are not

described in SPC. Unexpected include also side effects mentioned inSPC when these occur in higher frequencies then described.

Most cases of unexpected ADRs are associated with medicinesnewly introduced on the market

It has no sense to report expected adverse

In clinical praxis it is usually not easy to evaluate causality reportalso in cases you are not sure about causal relationship

Heathcare professionals may report adverse events also to marketingauthorization holder for a medicine but are not obligated to

Documents

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